Abstract
Objectives
This study analyzed the outcomes of patients who presented with non-ST-elevation myocardial infarction (NSTEMI) and subsequently underwent orbital atherectomy for severe coronary artery calcification (CAC).
Background
Patients who present with NSTEMI have increased risk for death and recurrent MI after percutaneous coronary intervention (PCI). Patients with severe CAC have worse outcomes after PCI.Orbital atherectomy modifies calcified plaque, facilitating stent delivery and optimizing stent expansion. There are no data on these patients who present with NSTEMI who undergo orbital atherectomy.
Methods
Of the 454 consecutive real-world patients who underwent orbital atherectomy in our retrospective multicenter registry, 51 patients (11.2%) presented with NSTEMI. The primary safety endpoint was the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30 days.
Results
Patients with NSTEMI had a higher prevalence of chronic kidney disease, lower mean ejection fraction, and required more vessels to be treated. The primary endpoint was similar in patients who presented with and without NSTEMI (2.0% vs. 2.2%, p = 0.9), as were the 30-day rates of death (2.0% vs. 1.2%, p = 0.67), MI (0% vs. 1.2%, p = 0.42), target vessel revascularization (0% vs. 0%, p > 0.91), and stroke (0% vs. 0.2%, p = 0.72). The rates of angiographic complications and stent thrombosis rate were low in both groups.
Conclusions
Despite having worse baseline characteristics, patients who presented with NSTEMI and subsequently underwent orbital atherectomy had similar clinical outcomes compared with patients without NSTEMI.
1
Introduction
Coronary artery calcification (CAC) is a marker of advanced atherosclerosis . Percutaneous coronary intervention (PCI) of severe CAC is technically more demanding as attempts to treat undilatable lesions can lead to perforation, dissection, and ischemia . These factors may explain the higher incidence of adverse cardiac events than in non-calcified lesions including death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis . Techniques to modify severe CAC before stent delivery and expansion are vital in decreasing mortality in these patients.
Although the ORBIT II trial reported excellent clinical outcomes following orbital atherectomy in 443 patients with severe CAC, patients with MI were excluded . We previously reported the safety and efficacy of all comers undergoing orbital atherectomy followed by stenting in a real-world multicenter registry of patients with severe CAC . Trials assessing rotational and orbital atherectomy have always excluded patients with thrombotic lesions. There are no data on outcomes of patients with MI who undergo orbital atherectomy. We report the outcomes of these high-risk patients with severe CAC who underwent orbital atherectomy.
2
Methods
2.1
Study population
This retrospective analysis included 454 consecutive real-world patients who underwent orbital atherectomy for severe CAC, defined by the presence of radio-opacities on fluoroscopy involving the vessel wall, between October 2013 and December 2015 at 3 centers (UCLA Medical Center, Los Angeles, CA, St. Francis Hospital, Roslyn, NY, and Northwell Health, Manhasset, NY).Patients were grouped by whether they underwent orbital atherectomy for non-ST-elevation MI ( n = 51) and those who did not ( n = 403). The institutional review board at each site approved the review of the data.
2.2
Device description
The coronary orbital atherectomy device (Cardiovascular Systems, Inc. [CSI], St Paul, MN) has a 1.25-mm crown coated with 30-μm diamonds and rotates on a 0.014″ ViperWire (CSI).The ViperSlide (CSI) lubricant is infused through the drive shaft to reduce friction during device advancement and activation. The mechanism of action is centrifugal force, in which the eccentrically mounted crown expands laterally, resulting in debulking and plaque modification.
2.3
Procedure and adjunctive pharmacotherapy
Standard techniques were used to perform PCI via a 6 French guiding catheter in all cases. It was the discretion of the operator to insert temporary pacing lead, use a hemodynamic support device, and image with intravascular imaging (intravascular ultrasound or optical coherence tomography).After low-speed (80,000 rpm) atherectomy, high-speed (120,000 rpm) atherectomy was considered if the reference vessel diameter was ≥3 mm. The duration of each pass was ≤20 s.
Aspirin was continued indefinitely.A P2Y12 inhibitor was continued for at least one month after bare metal stenting and at least 12 months after drug-eluting stenting.The choice of P2Y12 inhibitor, antithrombotic therapy, and use of glycoprotein IIb/IIIa antagonist was left to the discretion of the operator.
2.4
Endpoints
The primary endpoint was the 30-day rate of major adverse cardiac and cerebrovascular events (MACCE), defined as the occurrence of death, MI, TVR, and stroke. Myocardial infarction was defined as recurrent ischemic symptoms with new ST-segment elevation or re-elevation of cardiac markers to at least twice the upper limit of normal. Target vessel revascularization was defined as repeat revascularization of the target vessel. Stent thrombosis was defined per the Academic Research Consortium definition . Baseline demographic and procedural data and clinical outcomes were obtained from medical records and entered into a dedicated PCI database.
2.5
Statistical analysis
Continuous variables were expressed as mean and standard deviation and compared using Student t test. Categorical variables were expressed as percentages and compared using chi square test.A p -value < 0.05 was considered statistically significant.Statistical analysis was performed with GraphPad Prism 6 (GraphPad Software, Inc. La Jolla, CA).
2
Methods
2.1
Study population
This retrospective analysis included 454 consecutive real-world patients who underwent orbital atherectomy for severe CAC, defined by the presence of radio-opacities on fluoroscopy involving the vessel wall, between October 2013 and December 2015 at 3 centers (UCLA Medical Center, Los Angeles, CA, St. Francis Hospital, Roslyn, NY, and Northwell Health, Manhasset, NY).Patients were grouped by whether they underwent orbital atherectomy for non-ST-elevation MI ( n = 51) and those who did not ( n = 403). The institutional review board at each site approved the review of the data.
2.2
Device description
The coronary orbital atherectomy device (Cardiovascular Systems, Inc. [CSI], St Paul, MN) has a 1.25-mm crown coated with 30-μm diamonds and rotates on a 0.014″ ViperWire (CSI).The ViperSlide (CSI) lubricant is infused through the drive shaft to reduce friction during device advancement and activation. The mechanism of action is centrifugal force, in which the eccentrically mounted crown expands laterally, resulting in debulking and plaque modification.
2.3
Procedure and adjunctive pharmacotherapy
Standard techniques were used to perform PCI via a 6 French guiding catheter in all cases. It was the discretion of the operator to insert temporary pacing lead, use a hemodynamic support device, and image with intravascular imaging (intravascular ultrasound or optical coherence tomography).After low-speed (80,000 rpm) atherectomy, high-speed (120,000 rpm) atherectomy was considered if the reference vessel diameter was ≥3 mm. The duration of each pass was ≤20 s.
Aspirin was continued indefinitely.A P2Y12 inhibitor was continued for at least one month after bare metal stenting and at least 12 months after drug-eluting stenting.The choice of P2Y12 inhibitor, antithrombotic therapy, and use of glycoprotein IIb/IIIa antagonist was left to the discretion of the operator.
2.4
Endpoints
The primary endpoint was the 30-day rate of major adverse cardiac and cerebrovascular events (MACCE), defined as the occurrence of death, MI, TVR, and stroke. Myocardial infarction was defined as recurrent ischemic symptoms with new ST-segment elevation or re-elevation of cardiac markers to at least twice the upper limit of normal. Target vessel revascularization was defined as repeat revascularization of the target vessel. Stent thrombosis was defined per the Academic Research Consortium definition . Baseline demographic and procedural data and clinical outcomes were obtained from medical records and entered into a dedicated PCI database.
2.5
Statistical analysis
Continuous variables were expressed as mean and standard deviation and compared using Student t test. Categorical variables were expressed as percentages and compared using chi square test.A p -value < 0.05 was considered statistically significant.Statistical analysis was performed with GraphPad Prism 6 (GraphPad Software, Inc. La Jolla, CA).
3
Results
3.1
Baseline demographic and procedural characteristics
Patients with MI had a higher prevalence of chronic kidney disease (serum creatinine ≥ 1.5 mg/dl), history of MI, and lower mean ejection fraction ( Table 1 ). Patients with MI had more vessels treated and were more often treated with a glycoprotein IIb/IIIa antagonist ( Table 2 ).
| MI | No MI | p -Value | |
|---|---|---|---|
| N = 51 | N = 403 | ||
| Age (years) | 75.3 ± 1.6 | 73.5 ± 0.5 | 0.23 |
| Male gender | 30 (58.8) | 282 (70.0) | 0.11 |
| Diabetes mellitus | 26 (51.0) | 164 (40.6) | 0.17 |
| Hypertension | 48 (94.1) | 345 (85.6) | 0.09 |
| Current smoker | 4 (7.8) | 17 (4.2) | 0.25 |
| Chronic kidney disease (creatinine ≥ 1.5 mg/dl) | 20 (39.2) | 68 (16.9) | <0.0001 |
| History of myocardial infarction | 13 (25.5) | 58 (14.4) | 0.04 |
| Previous coronary artery bypass grafting | 6 (11.8) | 71 (17.6) | 0.29 |
| Previous percutaneous coronary intervention | 12 (23.5) | 150 (37.2) | 0.06 |
| Mean ejection fraction (%) | 46.4 ± 2.4 | 52.7 ± 0.53 | 0.0003 |
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